On January 18, 2018, Health Canada and the Institute for Safe Medication Practices Canada opened a consultation on the naming of biologic drugs (including biosimilars) in Canada.
As we reported, the US Food and Drug Administration began affixing a four-letter suffix to the generic name of biosimilar drugs, which is intended to facilitate pharmacovigilance and minimize inadvertent substitution of biologics that have not been deemed interchangeable. To date, Canada has not followed suit, and all biosimilars marketed in Canada have the same generic name without a suffix.
The objective of the consultation is to gain insight into stakeholder views on different approaches to naming biologics. Results of the consultation will be used to understand the impact of different approaches and inform Health Canada’s policy decision on a naming convention for biologic drugs.
The consultation consists of a brief questionnaire and will be open until February 9, 2018.